DIRECTORATE: GENETIC RESOURCES

DEPARTMENT OF AGRICULTURE, FORESTRY AND FISHERIES

13 September 2013

GENETICALLY MODIFIED ORGANISMS

SA REGULATORY FRAMEWORK

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Department of Agriculture, Forestry & Fisheries

Department of Environmental

Affairs

Department of Health

Department of Science &

Technology

Department of Trade and

Industry

NationalEnvironmentalManagement

Act, 1998

GMO Act, 1997(Amendment in

2006)

NationalEnvironmental

Biodiversity Act, 2004

Convention onBiological Diversity/Cartagena Protocol *Focal Point

Foodstuffs, Cosmetics, and Disinfectants

Act, 1972

CODEX AlimentariusContact Point

CartagenaProtocol for Biosafety-2003*Competent Authority

National Biotechnology

Strategy2001

Consumer Protection Act, 2008

Promulgated 1997 and implemented 1999Promulgated 1997 and implemented 1999

Objective – Objective – ensure activities relating to GMO’s are carried out RESPONSIBLYensure activities relating to GMO’s are carried out RESPONSIBLY import, export, production, use, release & distribution import, export, production, use, release & distribution limit adverse impact on environment, human/animal healthlimit adverse impact on environment, human/animal health effective management of wasteeffective management of waste measures to evaluate & reduce potential risksmeasures to evaluate & reduce potential risks criteria for risk assessmentcriteria for risk assessment

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GENETICALLY MODIFIED ORGANISMS ACT (Act No. 15 of 1997)

Act makes provision for the Minister to appoint members to Act makes provision for the Minister to appoint members to regulatory bodies which exercise oversight over the safety regulatory bodies which exercise oversight over the safety assessment and approval of GMO applications.assessment and approval of GMO applications.

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REGULATORY PROCESS

•Environmental Safety•Food & feed safety•Non safety issues e.g. trade & socio-economics

Registrar(Administration)

Executive Council (EC)Decision makers represented

Advisory CommitteeTechnical experts responsible for safety

assessment

ASSESSMENT PROCESS

ApplicationAdvisory

Committee

Advisory sub-Committee

Review CommitteeChair: AC member

Sub-committee membersExecutive Council

TIMELINE FOR APPLICATIONS: 30-270 DAYS

THE ADVISORY COMMITTEE SCIENTIFIC EXPERTISE• Agricultural biotechnology • Allergenecity• Bacteriology• Biotechnology

(medical/plant/veterinary/wine)• Botany• Ecology• Entomology• Food toxicology• Genetics• Microbiology• Molecular biology

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• Nutrition• Pharmacology• Plant biochemistry• Plant breeding • Plant physiology• Poultry science • Proteomics• Vaccine development• Virology

AC (10 members, Ministerial Appointments)AC (10 members, Ministerial Appointments)Sub-committee Sub-committee (54 members, appointed by Registrar)(54 members, appointed by Registrar)

DUTIES:DUTIES:National Advisory BodyScientific expertsPrimary safety assessment of applicationsSubcommittee –more expertiseRecommendation report to the EC

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THE ADVISORY COMMITTEE

Sub-Comm.Member

Sub-comm.Member

Sub-CommMember

Review Chairperson (AC member)

EXECUTIVE COUNCILEXECUTIVE COUNCIL

Appointed by DAFF Minister

Composition: DAFF, DEA, DST, the dti, DoH, DoL, DAC & AC Chair

Duties:• Advise the Minister on all matters• Considering recommendation of AC decide on an application• Compliance to their respective mandates• Approve relevant guidance documents• Recommendations on appointment of members of AC

Consensus decision-making

Engagement with interest groups/ applicants: At EC’s request

Non-CBI minutes available to public

GMO EVENTS APPROVED FOR CONDITIONAL COMMERCIAL RELEASE Use of event: importation/exportation, commercial planting and food and/or feed

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Company Crop Trait Year approved

Monsanto,Syngenta and Pioneer

Maize

Insect resistanceHerbicide tolerant (4)

2007, 2010, 2012

Herbicide tolerant(2) 2002, 2010

Insect resistance (3) 1997,2003, 2010

Monsanto Cotton

Insect resistantHerbicide tolerant (2)

2005, 2007

Insect resistant (2) 1997, 2003

Herbicide tolerant (2) 2000

Monsanto Soybean Herbicide tolerant (1) 2001

GMO EVENTS APPROVED FOR COMMODITY CLEARANCE Use of event: importation for food and/or feed

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Company Crop Trait Year approved

Monsanto,Syngenta Dow AgroScience and Pioneer

Maize

Insect resistanceHerbicide tolerant (19)

2002, 2003, 2004, 2011, 2012

Herbicide tolerant (4) 2011,2012

Insect resistance (8) 2011

Bayer Cotton Herbicide tolerant (1) 2011

AgrEvo, Dow AgroScience, BASF and Pioneer

Soybean Herbicide tolerant (6) 2013, 2012, 2001

Bayer RiceHerbicide tolerant (1)

2011

GMO EVENTS APPROVED FOR FIELD TRIAL (2012/2013)

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Company Oganism Trait

Triclinium

Wits Vaccines

TB

HIV

Syngenta, Pioneer and Monsanto

Maize

Insect resistanceHerbicide tolerant (9)Male fertilityFemale infertility (1)

Bayer Cotton Insect resistanceHerbicide tolerant (1)

ACTIVITIES REGULATED UNDER THE GMO ACT Import & Export

Contained use(Activities in laboratories, greenhouse, glasshouse depending oncontainment levels)

Trial release(Limited environmental release to provide for generation of SA data in

different agro-ecological zones)

General release (conditional)(Preceded by field trials, feeding studies, monitoring plan and annual reports)

Commodity Clearance (conditional)

COMMODITY CLEARANCES Use in food, feed and processing

Only food/ feed safety data considered

Special conditions for import: SABS standard• Limit environmental contact

Asynchrony limits commodity imports: lack of segregation

Imports usually for coastal regions

COMMODITY CLEARANCE APPLICATION-DOW AGRO Application for commodity clearance of GM maize event DAS-

40278-9, reference number Dow Agro Sciences -12/002

Short description of the genetic modification   GM maize has been modified to be resistant to the herbicide 2, 4-

dichlorophenoxyacetic acid (commonly referred to as 2,4-D). This trait is achieved through the expression of a protein

(enzyme) in the maize which degrades 2.4D into herbicidally-inactive 2, 4-dichlorophenol (DCP).

This means that in the production of the GM maize, a herbicide spraying regime may be applied which will not affect the GM maize.

Public Notification

Sunday Times, City Press & Rapport newspapers of 04 March 2012.

Notices include: Applicant Type of Application Origin of the inserted gene Call for comments Deadline for comments

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CONTD...

Public notifications of the intended activity were placed in the Sunday Times, City Press and Rapport newspapers of 04 March 2012.

Received by the Office of the Registrar 05 March 2012

No comments were submitted by the public

ACB PAIA request -EC Decision document July 2012

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Thank you

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